SGLT2 Inhibitors and TZD for Type 2 Diabetes on DPP4 Inhibitors
Sitagliptin 100 mg
+ Sitagliptin 100 mg + Dapagliflozin 10 mg
+ Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg
Diabetes Mellitus+6
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: September 1, 2025
Actual date on which the first participant was enrolled.This clinical trial is designed to explore new ways to improve blood sugar control in people with type 2 diabetes who are already taking a type of medication known as DPP4 inhibitors. The study tests three different strategies: using an SGLT2 inhibitor alone, using a TZD alone, or combining both medications, compared to continuing with just the DPP4 inhibitor. The goal is to see if adding these medications can better manage blood sugar levels, which is crucial for preventing complications of diabetes. This trial is important for adults between 19 and 75 years old with type 2 diabetes who have been on stable diabetes medication. Participants in the study will be randomly placed into one of four groups. Each group will follow a specific medication plan for either 12 or 24 weeks. The main focus is on changes in HbA1c levels, a marker of long-term blood sugar control. Researchers will also look at other factors like fasting and after-meal blood sugar levels, insulin levels, cholesterol, and body composition. The trial is conducted at multiple hospitals in Korea, with all medications provided by the study sponsor. Participants will also receive advice on diet and exercise to support their treatment. Regular safety checks will ensure any side effects are promptly addressed.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 19 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
Seoul, South KoreaOpen Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea in Google Maps